Remote Product Quality & Complaints Lead

Sumitomo Pharma; Annapolis (MD); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America seeks a PV Quality Assurance professional for a primarily remote role to manage intake, assessment, investigation, and closure of product complaints for commercial and clinical products, ensuring regulatory compliance. Reports to the Senior Director, PV Quality Assurance within the Quality department.

Collaborate with Pharmacovigilance, Manufacturing, QA, and external partners to support product quality and patient safety.

Qualifications

• Bachelor’s degree in a related field required.
• Minimum 4 years of relevant experience in biotech or pharmaceutical industry.
• Solid experience with product complaints, investigations, quality systems, and regulatory compliance activities.
• Working knowledge of cGMP requirements and quality management systems.

Responsibilities

• Manage intake, assessment, documentation, investigation, and closure of product complaints per regulations.
• Receive and process complaints, including potential adverse event and product quality reports.
• Coordinate investigations with internal and external stakeholders to support evaluations.
• Maintain complaint records to be inspection-ready and well-documented.
• Coordinate sample return, testing requests, and related documentation.
• Draft and issue complaint communications as required.
• Ensure compliance with cGMP, regulatory expectations, and internal procedures.

Skills

FDA regulations

GMP knowledge

Investigation

Risk assessment

eQMS

Documentation

Education

Bachelor's degree

Tools

eQMS system

Complaint databases

Job description

Sumitomo Pharma America seeks a PV Quality Assurance professional for a primarily remote role to manage intake, assessment, investigation, and closure of product complaints for commercial and clinical products, ensuring regulatory compliance. Reports to the Senior Director, PV Quality Assurance within the Quality department.

Collaborate with Pharmacovigilance, Manufacturing, QA, and external partners to support product quality and patient safety.